PuraPly® AM Plus the Standard of Care to Standard of Care Alone for the Management of Stage II-IV Pressure Ulcers.

NCT ID: NCT03502824

Last Updated: 2021-09-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2021-09-15

Brief Summary

This is a prospective, multi-center, randomized, controlled clinical study Of PuraPly® AM and standard of care (SOC) compared to SOC alone for the management of Stage II-IV pressure ulcers located in the gluteal, ischial, hip, sacral, coccygeal, and trochanteric, malleolus, or heel area.

Detailed Description

This study seeks to demonstrate how PuraPly® AM performs against standard of care in Stage II-IV Pressure Ulcers through a prospective randomized controlled study design.

Subjects may be enrolled for up to 24 weeks; if healing occurs prior to week 24, a follow up healing confirmation visit shall occur two weeks later to confirm maintenance of complete wound closure and participation may continue up to 24 weeks. Subjects that are randomized to the SOC group have the opportunity to cross over and receive PuraPly AM at week 12 if their index ulcer has not healed; they will then be followed for an additional 12 weeks for up to 24 weeks.

Conditions

Chronic Pressure Ulcers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

PuraPly® AM plus Standard of Care

Group Type: ACTIVE_COMPARATOR

PuraPly® Antimicrobial Wound Matrix

Intervention Type: DEVICE

PuraPly® AM is a class II medical device, that has been 510(k) cleared by US Food and Drug Administration (FDA) (K051647) and is intended for the management of acute and chronic wound management across a variety of wound types, including partial- and full-thickness wounds, pressure ulcers, surgical wounds, trauma wounds, venous and diabetic ulcers.

Standard of Care (SOC) for Pressure Ulcers

Group Type: ACTIVE_COMPARATOR

SOC for Pressure Ulcers

Intervention Type: OTHER

SOC group will receive institutional standard of care which includes, but is not limited to, debridement, negative pressure wound therapy (i.e. VAC), ensuring perfusion and oxygenation, evaluating nutritional status and addressing deficits, offloading, keeping the ulcer bed moist with appropriate cleansing at the time of each dressing change. Standard dressings may include hydrocolloids, alginates, transparent film, foam, moist gauze dressings. In addition, a non-toxic topical antiseptic, may be used per NPUAP Clinical Practice Guidelines (2014) for SOC group only, if colonization is suspected.

Interventions

PuraPly® Antimicrobial Wound Matrix

PuraPly® AM is a class II medical device, that has been 510(k) cleared by US Food and Drug Administration (FDA) (K051647) and is intended for the management of acute and chronic wound management across a variety of wound types, including partial- and full-thickness wounds, pressure ulcers, surgical wounds, trauma wounds, venous and diabetic ulcers.

Intervention Type: DEVICE

SOC for Pressure Ulcers

SOC group will receive institutional standard of care which includes, but is not limited to, debridement, negative pressure wound therapy (i.e. VAC), ensuring perfusion and oxygenation, evaluating nutritional status and addressing deficits, offloading, keeping the ulcer bed moist with appropriate cleansing at the time of each dressing change. Standard dressings may include hydrocolloids, alginates, transparent film, foam, moist gauze dressings. In addition, a non-toxic topical antiseptic, may be used per NPUAP Clinical Practice Guidelines (2014) for SOC group only, if colonization is suspected.

Intervention Type: OTHER

Other Intervention Names

PuraPly® AM

Eligibility Criteria

Inclusion Criteria

1. Subject must be at least 18 years of age.

2. Subject has a Stage II-IV pressure ulcer located in the gluteal, ischial, hip, sacral, coccygeal, and trochanteric, malleolus, or heel area.

3. Pressure ulcer should be present for 4 weeks duration and have a ulcer surface area > 2cm2

4. If multiple ulcers are present, one ulcer must be identified as the index ulcer.

5. The index ulcer is free from active infection at the time of randomization.

6. Willingness to off-load or pressure redistribute ulcer for duration of enrollment

7. The index ulcer has been offloaded for at least 7 days prior to randomization.

8. The index ulcer must have been present for at least 30 days at time of study enrollment.

9. The index ulcer is separated at least 4 cm from all other ulcers at Study Day -7 and Study Day 0 (post-debridement) and has a margin of intact skin sufficient for anchoring of the required study dressing.

10. Subject has read and signed the IRB/IEC approved Informed Consent Form (ICF) before screening procedures are undertaken.

Exclusion Criteria

1. Presence of signs and symptoms of infection at the index ulcer site, including but not limited to cellulitis, acute osteomyelitis, excessive exudate, gangrene or deep tissue infection

2. The index ulcer is not free of necrotic tissue and is unable to tolerate debridement

3. Non-enteric or unexplored sinus tract

4. Concomitant conditions that in the judgment of the investigator would make the subject inappropriate for entry to the study

5. Subject has a known sensitivity to porcine materials

6. Subject has a known sensitivity to polyhexamethylenebiguanide (PHMB)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organogenesis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Gorenstein, MD FACEP

Role: PRINCIPAL_INVESTIGATOR

NYU Winthrop Hospital

Alisha Oropallo, MD, FACS, APWCA

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

Northwell Health

Lake Success, New York, United States

NYU Winthrop Hospital

Mineola, New York, United States

Countries

United States

Other Identifiers

17-PRU-004-PPAM

Identifier Type: -

Identifier Source: org_study_id